Trial Outcomes & Findings for Neck Cooling as a Non-Invasive Method to Lower Brain Temperature in Healthy Adults (NCT NCT04973085)

NCT ID: NCT04973085

Last Updated: 2023-09-13

Results Overview

During each intervention, core brain temperature was measured non-invasively, in one-minute increments, using MR thermometry. The change in brain temperature was calculated as the difference of differences between the cold and body-temperature interventions, after 1 hour.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 60 minutes
• Results posted on: 2023-09-13

Participant Flow

22 subjects were screened for study eligibility between July, 2021 and February, 2022.

Subjects were randomized to either the cold or body-temperature water arm at the MRI research center immediately prior to their first intervention.

Participant milestones

Measure	Cold (Intervention 1) Then Body-temperature (Intervention 2) Circulated Water Participants first underwent the intervention with cold circulated water. Then, on a separate day, they repeated the intervention with body-temperature water.	Body-temperature (Intervention 1) Then Cold (Intervention 2) Circulated Water Participants first underwent the intervention with body-temperature circulated water. Then, on a separate day, they repeated the intervention with cold water.
First Intervention STARTED	10	12
First Intervention COMPLETED	9	12
First Intervention NOT COMPLETED	1	0
Second Intervention STARTED	9	12
Second Intervention MRI Adjusted Protocol	7	9
Second Intervention COMPLETED	7	9
Second Intervention NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Cold (Intervention 1) Then Body-temperature (Intervention 2) Circulated Water Participants first underwent the intervention with cold circulated water. Then, on a separate day, they repeated the intervention with body-temperature water.	Body-temperature (Intervention 1) Then Cold (Intervention 2) Circulated Water Participants first underwent the intervention with body-temperature circulated water. Then, on a separate day, they repeated the intervention with cold water.
First Intervention Claustrophobia in the MRI machine.	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Analyzed Participants n=17 Participants All analyzed participants.	Participants Used to Modify MRI Protocol n=5 Participants Participants whose data was used to modify the MRI protocol.	Total n=22 Participants Total of all reporting groups
Age, Continuous	31.1 years STANDARD_DEVIATION 10.9 • n=17 Participants	21.1 years STANDARD_DEVIATION 1.8 • n=5 Participants	28.9 years STANDARD_DEVIATION 10.5 • n=22 Participants
Sex: Female, Male Female	10 Participants n=17 Participants	2 Participants n=5 Participants	12 Participants n=22 Participants
Sex: Female, Male Male	7 Participants n=17 Participants	3 Participants n=5 Participants	10 Participants n=22 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 60 minutes

Population: Two participants were excluded from the analyses, including one who was not able to complete the interventions due to claustrophobia, and one who had incomplete data due to documented head movement.

During each intervention, core brain temperature was measured non-invasively, in one-minute increments, using MR thermometry. The change in brain temperature was calculated as the difference of differences between the cold and body-temperature interventions, after 1 hour.

Outcome measures

Measure	Cold Circulated Water n=15 Participants Participants undergoing the intervention with cold circulated water.	Body-temperature Circulated Water n=15 Participants Participants undergoing the intervention with body-temperature circulated water.
Change in Brain Temperature	-0.23 degrees Celsius Interval -0.37 to -0.1	-0.03 degrees Celsius Interval -0.14 to 0.09

SECONDARY outcome

Timeframe: 120 minutes

Outcome measures

Measure	Cold Circulated Water n=15 Participants Participants undergoing the intervention with cold circulated water.	Body-temperature Circulated Water n=15 Participants Participants undergoing the intervention with body-temperature circulated water.
Modified Bedside Shivering Assessment Number of participants with BSAS score = 0 (none)	15 Participants	15 Participants
Modified Bedside Shivering Assessment Number of participants with BSAS score = 1 (mild)	0 Participants	0 Participants
Modified Bedside Shivering Assessment Number of participants with BSAS score = 2 (moderate)	0 Participants	0 Participants
Modified Bedside Shivering Assessment Number of participants with BSAS score = 3 (severe)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 120 minutes

Change in systolic blood pressure during the intervention.

Outcome measures

Measure	Cold Circulated Water n=15 Participants Participants undergoing the intervention with cold circulated water.	Body-temperature Circulated Water n=15 Participants Participants undergoing the intervention with body-temperature circulated water.
Systolic Blood Pressure	-1.7 mmHg Interval -4.8 to 1.4	2.9 mmHg Interval 0.4 to 5.5

SECONDARY outcome

Timeframe: 120 minutes

Outcome measures

Measure	Cold Circulated Water n=15 Participants Participants undergoing the intervention with cold circulated water.	Body-temperature Circulated Water n=15 Participants Participants undergoing the intervention with body-temperature circulated water.
Diastolic Blood Pressure	2.8 mmHg Interval 0.5 to 5.1	0.8 mmHg Interval -1.7 to 3.3

SECONDARY outcome

Timeframe: 120 minutes

Outcome measures

Measure	Cold Circulated Water n=15 Participants Participants undergoing the intervention with cold circulated water.	Body-temperature Circulated Water n=15 Participants Participants undergoing the intervention with body-temperature circulated water.
Heart Rate	-2.0 beats per minute Interval -4.0 to 0.1	0.2 beats per minute Interval -2.8 to 3.3

Adverse Events

Cold Circulated Water

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Body-temperature Circulated Water

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cold Circulated Water n=22 participants at risk Adverse events occurring during the cold intervention.	Body-temperature Circulated Water n=21 participants at risk Adverse events occurring during the body-temperature intervention.
Investigations Claustrophobia in the MRI scanner	4.5% 1/22 • Number of events 1 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."	0.00% 0/21 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."
Skin and subcutaneous tissue disorders Skin discomfort	4.5% 1/22 • Number of events 1 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."	0.00% 0/21 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."
Musculoskeletal and connective tissue disorders Stiff neck	4.5% 1/22 • Number of events 1 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."	0.00% 0/21 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."
Nervous system disorders Headache	4.5% 1/22 • Number of events 1 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."	4.8% 1/21 • Number of events 1 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."
Ear and labyrinth disorders Dizziness	4.5% 1/22 • Number of events 1 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."	4.8% 1/21 • Number of events 1 • 120 minutes Adverse event information was collected immediately after each intervention, by asking participants: "Did you experience any adverse effects during the intervention? If yes, please explain."

Additional Information

Adam Sprouse Blum, MD

University of Vermont

Phone: 8028478050

Email: Adam.Sprouse-Blum@uvmhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place